Moderna, Merck's Phase 2b Trial Of MRNA-4157/V940 Combination In Melanoma Meets Primary Endpoint

(RTTNews) - Moderna, Inc. (MRNA) and Merck (MRK) Tuesday announced that the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial of mRNA-4157/V940, in combination with Merck's anti-PD-1 therapy KEYTRUDA, demonstrated a statistically significant improvement in the primary endpoint of recurrence-free survival versus KEYTRUDA alone.

The companies noted that the adjuvant treatment in patients, with stage III/IV melanoma following complete resection, using mRNA-4157/V940 combination reduced the risk of recurrence or death by 44 percent; compared with KEYTRUDA alone. Melanoma is a serious form of skin cancer, characterized by the uncontrolled growth of pigment-producing cells.

Moderna said, for the first time ever, the potential for mRNA was demonstrated to have an impact on outcomes in a randomized clinical trial in melanoma.

The company plans to start additional studies in melanoma and other forms of cancer with the goal of bringing individualized cancer treatments to patients. Phase 3 study will be initiated in melanoma patients in 2023.

The findings from the Phase 2 b trial are said to be the first randomized evidence that a personalized neoantigen approach may be beneficial in melanoma.